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Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use

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ClinicalTrials.gov Identifier: NCT01714063
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Asthma
Intervention Device: Pressurized Metered-Dose Inhaler
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pressurized Metered-Dose Inhaler
Hide Arm/Group Description All participants that were consented to use the Pressurized Metered-Dose Inhaler in this study were considered.
Period Title: Overall Study
Started 34
Completed 32
Not Completed 2
Reason Not Completed
Equipment malfunction             2
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants that were consented to the study were considered.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
6.4  (0.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
12
  37.5%
Male
20
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
17
  53.1%
More than one race
0
   0.0%
Unknown or Not Reported
15
  46.9%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 32 participants
119.3  (7.7)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 32 participants
26.4  (8.6)
Time Using Valved Holding Chamber  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
3  (2.5)
Previous Mouthpiece Experience  
Mean (Standard Deviation)
Unit of measure:  Percentage of participants
Number Analyzed 32 participants
13  (41)
1.Primary Outcome
Title Delivered Dose of Fluticasone (on the Filter)
Hide Description This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Age 5-6.5 Aged 6.6- 8 Years
Hide Arm/Group Description:

Group 1 will consist of 16 children aged 5-6.5 years

Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler

Group 2 will consist of 16 children aged 6.6- 8 years

Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler

Overall Number of Participants Analyzed 16 16
Mean (99% Confidence Interval)
Unit of Measure: Percent filter dose of fluticasone
Coordinated
48
(44 to 52)
45
(39 to 51)
Uncoordinated
41
(36 to 47)
40
(35 to 45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Age 5-6.5, Aged 6.6- 8 Years
Comments [Not Specified]
Type of Statistical Test Other
Comments We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
2.Primary Outcome
Title Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers
Hide Description This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was excluded from the filter data because they were an outlier
Arm/Group Title All Participants
Hide Arm/Group Description:
Data among all participants were compared for the coordinated and uncoordinated effort
Overall Number of Participants Analyzed 31
Mean (99% Confidence Interval)
Unit of Measure: Percent filter dose of fluticasone
Coordinated
46
(43 to 50)
Uncoordinated
41
(37 to 44)
3.Secondary Outcome
Title Inspiratory Peak Flow
Hide Description

Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.

This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
  1. participant was excluded from both the coordinated because of their breathing profile
  2. participants were excluded from the uncoordinated effort because of their breathing profile
Arm/Group Title Coordinated Effort Uncoordinated Effort
Hide Arm/Group Description:
Data among all participants were compared for the coordinated maneuver.
Data among all participants were compared for the uncoordinated maneuver.
Overall Number of Participants Analyzed 31 30
Mean (99% Confidence Interval)
Unit of Measure: L/min
1st Breath
25.2
(20.5 to 30)
22.8
(17.6 to 28.1)
2nd Breath
23.3
(18.5 to 28.1)
22
(17.3 to 26.6)
3rd Breath
23.2
(18.3 to 28)
22.5
(17.1 to 27.9)
All Breaths
23.9
(21.3 to 26.5)
22.4
(19.6 to 25.2)
4.Secondary Outcome
Title Inspiratory Tidal Volume
Hide Description

Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.

This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
  1. participant was excluded from both the coordinated because of their breathing profile
  2. participants were excluded from the uncoordinated effort because of their breathing profile
Arm/Group Title Coordinated Effort Uncoordinated Effort
Hide Arm/Group Description:
Data among all participants were compared for the coordinated maneuver.
Data among all participants were compared for the uncoordinated maneuver.
Overall Number of Participants Analyzed 31 30
Mean (99% Confidence Interval)
Unit of Measure: mL
1st Breath
286
(209 to 363)
269
(212 to 362)
2nd Breath
281
(215 to 363)
259
(186 to 333)
3rd Breath
302
(227 to 378)
266
(201 to 331)
All
291
(250 to 332)
271
(228 to 314)
5.Other Pre-specified Outcome
Title Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC
Hide Description Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This is a measure of an inhaler study, not a nebulizer study. Therefore this data was not collected or analyzed as it would not be applicable to this type of study.
Arm/Group Title Coordinated Effort Uncoordinated Effort
Hide Arm/Group Description:
Data among all participants were compared for the coordinated maneuver.
Data among all participants were compared for the uncoordinated maneuver.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants that were consented to the study were considered.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/34 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ariel Perlinkski MT
Organization: Department of Pediatrics UAMS/COM
EMail: berlinskiariel@uams.edu
Layout table for additonal information
Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01714063    
Other Study ID Numbers: RDD-2010-001
First Submitted: October 18, 2012
First Posted: October 25, 2012
Results First Submitted: January 9, 2019
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019